BUDIAIR 200 MICROGRAMS Pressurized solution for inhalation

Зміст інструкції

1. BUDIAIR 200 micrograms per actuation pressurized solution for inhalation
   1. What you need to know before you take BUDIAIR
   2. How to take BUDIAIR
   3. Possible side effects
   4. How to store BUDIAIR
   5. Package contents and other information
2. BUDIAIR 200 micrograms pressurised solution for inhalation
   1. What you need to know before you take BUDIAIR
   2. How to take BUDIAIR
   3. Possible side effects
   4. How to store BUDIAIR
   5. Package contents and other information

BUDIAIR 200 micrograms per actuation pressurized solution for inhalation

with standard actuator
budesonide

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful for people other than you, even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What BUDIAIR is and what it is used for
• 2. What you need to know before you take BUDIAIR
• 3. How to take BUDIAIR
• 4. Possible side effects
• 5. How to store BUDIAIR
• 6. Contents of the pack and other information

1 What BUDIAIR is and what it is used for
BUDIAIR is a pressurized solution for inhalation containing an active ingredient that is inhaled
through the mouth and released directly into the lungs. The active ingredient budesonide belongs to the group
of medicines called corticosteroids, which are often simply referred to as steroids and have
an anti-inflammatory action by reducing swelling and irritation of the walls of the small airways in the
lungs.
BUDIAIR is a maintenance medicine: it treats inflammation and is used to prevent the symptoms
of asthma. It cannot stop an asthma attack that has already started. To relieve your symptoms you should
use your reliever inhaler as needed, which you should always carry with you.

BUDIAIR is used for:
Treatment of mild, moderate and severe persistent bronchial asthma.

2. What you need to know before you take BUDIAIR

Do not take BUDIAIR

• If you are allergic to budesonide or any of the other ingredients of this medicine (listed in section 6).

Contact your doctor for advice.
1

Warnings and precautions
Talk to your doctor or pharmacist before taking BUDIAIR

• if you suffer from severe liver disorders
• if you suffer from gastrointestinal ulcer
• if you are taking or have taken medicines to treat tuberculosis (TB) or other respiratory infections
• if you are pregnant or have planned a pregnancy or if you are breastfeeding

During therapy, if oral candidiasis occurs, tell your doctor, as antifungal therapy or discontinuation of treatment may be necessary. In order to reduce the risk of oral candidiasis and hoarseness, see section 3: How to take BUDIAIR.
In case of paradoxical bronchospasm, with immediate increase of wheezing after administration, treatment must be immediately interrupted.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
It is important to monitor the height of children receiving prolonged treatment and discuss it with the treating doctor.

Other medicines and BUDIAIR
Tell your doctor if you are taking or have recently taken or may take any other medicine, including medicines obtained without a prescription.
It is particularly important to tell your doctor if you are taking:

• medicines containing corticosteroids
• antifungals, such as ketoconazole or itraconazole
• medicines that contain disulfiram or metronidazole (see “BUDIAIR contains glycerol and ethanol”)
• HIV protease inhibitors or other potent CYP3A4 inhibitors
• estrogens and contraceptive steroids

Some medicines can increase the effects of BUDIAIR and your doctor may want to keep you under close observation if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
If you are taking any of the medicines mentioned above, your doctor may prescribe another medicine or adjust the dose of BUDIAIR or the other medicine.
If you perform an ACTH stimulation test for the diagnosis of pituitary insufficiency, the test may show false results (low values).
Your doctor may have given you other medicines for your breathing problems. It is very important to continue to use these products regularly. DO NOT STOP USING THEM and do not change the dose when you start using BUDIAIR.
2

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you become pregnant while taking BUDIAIR, consult your doctor immediately.
Worldwide experience with inhaled budesonide has not been able to detect an increased risk of adverse effects for the fetus and newborn during pregnancy.
Budesonide can be taken during breastfeeding.

Driving and using machines
BUDIAIR does not impair your ability to drive or use machines.

BUDIAIR contains glycerol and ethanol.
This medicine contains 8.4 mg of alcohol (ethanol) per actuation which is equivalent to 0.12 mg/kg per administration in adults and 0.42 mg/kg in children. The amount in one actuation of this medicine is equivalent to less than 1 ml of wine or beer. The small amount of alcohol in this medicine will not have noticeable effects.
Ethanol can cause problems in particularly sensitive patients treated with medicines containing disulfiram or metronidazole.
This medicine contains glycerol: it can cause headache, stomach upset and diarrhea.
Attention for those who play sports: the product contains substances prohibited for doping. Taking it in a manner different from the therapeutic indications, dosage regimen and route of administration is prohibited.

3. How to take BUDIAIR

BUDIAIR is for inhalation use.
Always take this medicine exactly as your doctor has told you. If you have doubts, ask your doctor
or pharmacist.
Your doctor will check you regularly to make sure you are taking the optimal dose of BUDIAIR.
The doctor will adjust your treatment to the lowest dose (maintenance dose) that can best control your
symptoms. Under no circumstancesshould you change the dose without first talking to your
doctor.
It is important that you take BUDIAIR for the entire period prescribed by your doctor.
This medicine will take a few days to become effective. It is very important that you use it regularly.

Adults and adolescents
The recommended dose is 200 micrograms (one actuation) 2-4 times a day. The maintenance dose is
generally 200 micrograms (one actuation) per day.
The maximum daily dose is 1600 micrograms.
3

Use in children
Children aged 6 to 12 years
The recommended dose is 200 micrograms (one actuation) per day. The maximum daily dosage is
400 micrograms.
If BUDIAIR is to be used by your child, make sure he/she is able to use it correctly.
Inhalation in children should be supervised by an adult. It is useful to close the child's nostrils during
inhalation.

Taking corticosteroids
If you have just started using BUDIAIR instead of taking corticosteroid tablets or if you are taking higher doses of
inhaled corticosteroids for long periods of time, you may need extra steroids
in stressful situations. Stressful situations can include being admitted to hospital after an accident, having
serious injuries or during periods before surgery. In this case, the doctor treating you will decide if
you need to increase your corticosteroid dose and may prescribe you some steroid tablets or a
steroid injection.

How to take BUDIAIR
See “Instructions for use of the inhaler” at the end of this leaflet.
It is recommended to rinse your mouth well with water, then spit it out, after each use of the aerosol dose
in order to reduce the risk of a possible Candida infection.

If you take moreBUDIAIR than you should
you should increase or decrease the dose without first consulting your doctor.
If you happen to accidentally take too many doses, contact your doctor as soon as possible.

If you forget to take BUDIAIR
If you accidentally forget to take a dose, take the next dose normally. Do not take
a double dose to make up for the missed one.

If you stop taking BUDIAIR
Do not stop taking treatment even if you feel better without talking to your doctor first. If
you suddenly stop taking this medicine, your asthma condition may worsen.

If your asthma gets worse
If your symptoms worsen or are difficult to control (e.g. if you are using your quick-relief asthma medicine
more frequently) or if your quick-relief asthma medicine does not improve your
symptoms, see your doctor immediately. Asthma may be getting worse and your doctor may
need to change your dose of BUDIAIR or prescribe you alternative treatment.
If you are switching from steroid tablets to inhaled therapy you may not feel well, even if your chest symptoms
are improving. Talk to your doctor, but DO NOT STOP treatment before you
are told to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If side effects do occur, they are likely to be mild and temporary. However, some
effects can be serious and require medical attention.
Possible side effects are listed below:

Common(may affect up to 1 in 10 people)
Change of voice (hoarseness), cough, sore throat, fungal infections of the mouth (oropharyngeal candidiasis),
difficulty swallowing.

Uncommon(may affect up to 1 in 100 people)
Anxiety, depression, tremor, cataract, blurred vision, muscle spasms

Rare(may affect up to 1 in 1,000 people)
Easy bruising, thinning of the skin, rash or hives, skin inflammations
(dermatitis), itching, abnormal skin redness (erythema), anaphylactic reactions, angioedema, levels
too high or too low of cortisol in the blood (hypercortisolism or hypocortisolism), narrowing of the airways
(bronchospasm).
Restlessness, nervousness, irritability, mental disorders (psychosis), and behavioral changes. These effects
occur more frequently in children.

Very rare (may affect up to 1 in 10,000 people)
Taste abnormalities and alterations (dysgeusia), nausea, burning sensation on the tongue (glossodynia), inflammation of the
mouth (stomatitis), dry mouth, back pain.

Not known (frequency cannot be estimated based on available data)
Sleep problems, aggressive reactions and increased psychomotor activity (mainly in children).
Increased pressure in the eyeball (glaucoma).

Rare serious allergic reactions
If they appear shortly after taking a dose, itching, allergic reaction with skin redness, swelling of the
face, very low blood pressure and irregular heartbeat (anaphylactic reaction), swelling of the face, eyes,
lips, tongue, throat or difficulty breathing (angioedema), immediate or delayed allergic reactions:

• stop taking BUDIAIR
• seek medical attention immediately

Shortness of breath immediately after taking a dose
Rarely, inhaled medicines can cause an increase in wheezing and shortness of breath (bronchospasm)
immediately after taking the dose. If this happens:

• stop using BUDIAIR immediately
• use your quick-relief inhaler immediately to treat the symptoms of shortness of breath and wheezing.
• contact your doctor immediately

5

The use of high doses of inhaled corticosteroids for long periods can cause systemic effects
Rarely delayed growth in children and adolescents and adrenal gland malfunction
(adrenal suppression), very rarely reduced bone mineral density (thinning of the
bones). With unknown frequency, sleep disorders may occur (more likely in children).

Reporting of side effects
If you get any side effects, even if not listed in this leaflet, tell your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can
help provide more information on the safety of this medicine.

5. How to store BUDIAIR

• Keep this medicine out of the sight and reach of children
• Do not use this medicine after the expiry date which is stated on the label and the packaging. The expiry date refers to the last day of that month
• Store the inhaler below 25 C
• The container contains a pressurized liquid. Do not puncture, do not expose to heat, even if empty, do not freeze or expose to direct sunlight
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help protect the environment

6. Package contents and other information

What BUDIAIR contains
The active substance is budesonide. Each actuation contains 200 micrograms of budesonide.
The other ingredients are: norflurane (HFC 134a), anhydrous ethanol and glycerol.
This medicine contains fluorinated greenhouse gases.
Each inhaler contains 11,200 g of norflurane (HFC-134a) which corresponds to 0.016 tonnes of
CO2 equivalent (global warming potential GWP = 1430).

What BUDIAIR looks like and the contents of the pack
Budiair is a pressurised inhalation solution contained in an aluminium canister with a plastic mouthpiece.
Each pack contains 1 inhaler which delivers 200 doses.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A. via Palermo 26/A, 43122 Parma, Italy

Manufacturer
Chiesi Farmaceutici S.p.A., Via San Leonardo 96, 43122 Parma, Italy

Alternative batch release:
All-Gen Pharmaceuticals &Generics BV, Rouboslaan 32 – 2252 TR Voorschoten– Netherlands
Chiesi Pharmaceuticals GmbH– Gonzagagasse 16/16 – 1010 Wien – Austria
6

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Italy BUDIAIR
Greece BUDIAIR
Netherlands Budesonide All-Gen
Poland BUDIAIR
Czech Republic BUDIAIR
Slovenia BUDIAIR
7

Instructions for using the inhaler
BUDIAIR is easy to use. Read all these instructions carefully before using it: they explain what you must do
and what you should pay attention to.
Effective treatment results depend on correct use of the inhaler.
Inhaler function test: before using the inhaler for the first time, or if you have not used it for three
days or more, remove the mouthpiece cap by pressing lightly on its sides and release one actuation
into the air to ensure that your inhaler is working correctly.

Opening the pack
When you open the carton, the inhaler is closed with the mouthpiece cap.

Taking a dose from BUDIAIR
Figures 1-2 Hold the inhaler between your thumb and forefinger, with the mouthpiece facing downwards. Remove the
mouthpiece cap.
Figures 3 a-b Exhale slowly (3a), then place the mouthpiece firmly between your lips (3b).
Figures 4 a-b-c Start to inhale slowly and deeply through your mouth and at the same time press
once on the top of the inhaler (4a). After inhalation, hold your breath for as long as
possible (4b). Once you have completed the prescribed number of inhalations, replace the
cap on the mouthpiece (4c).
If the medicine is to be used by your child, it is helpful to close their nostrils during inhalation.
1-2 3a 3b 4a 4b
4c

Cleaning
The mouthpiece should always be kept clean. To clean it, remove the pressurised canister and
rinse the mouthpiece with warm water. Allow to dry completely in a warm place.
8

BUDIAIR 200 micrograms pressurised solution for inhalation

with Jet spacer device
budesonide

Read all of this leaflet carefully before you start taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may be harmful for people other than you, even if their symptoms are the same as yours.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What BUDIAIR is and what it is used for
• 2. What you need to know before you take BUDIAIR
• 3. How to take BUDIAIR
• 4. Possible side effects
• 5. How to store BUDIAIR
• 6. Contents of the pack and other information

1 What BUDIAIR is and what it is used for
BUDIAIR is a pressurised solution for inhalation containing an active ingredient that is inhaled
through the mouth and released directly into the lungs. The active ingredient budesonide belongs to the group
of medicines called corticosteroids, which are often simply referred to as steroids, and have
an anti-inflammatory action that reduces swelling and irritation of the walls of the small airways
in the lungs.
BUDIAIR is a preventative medicine: it treats inflammation and is used to prevent the symptoms
of asthma. It cannot stop an asthma attack that has already started. To relieve your symptoms you should
use your reliever inhaler as needed, which you should always carry with you.

BUDIAIR is used for:
Treatment of mild, moderate and severe persistent bronchial asthma.

2. What you need to know before you take BUDIAIR

Do not take BUDIAIR:

• If you are allergic to budesonide or to any of the other ingredients of this medicine (listed in section 6).

Contact your doctor for advice.
9

Warnings and precautions:
Talk to your doctor or pharmacist before taking BUDIAIR

• if you suffer from severe liver disorders
• if you suffer from gastrointestinal ulcer
• if you are taking or have taken medicines to treat tuberculosis (TB) or other respiratory infections
• if you are pregnant or have planned a pregnancy or if you are breastfeeding

During therapy, if oral candidiasis develops, tell your doctor, as antifungal therapy or discontinuation of treatment may be necessary. In order to reduce the risk of oral candidiasis and hoarseness, see section 3: How to take BUDIAIR.
In case of paradoxical bronchospasm, with immediate increase in wheezing after administration, treatment should be stopped immediately.
Contact your doctor if you experience blurred vision or other visual disturbances.

Children and adolescents
It is important to monitor the height of children receiving prolonged treatment and discuss this with their doctor.

Other medicines and BUDIAIR
Tell your doctor if you are taking or have recently taken or may take any other medicines, including medicines obtained without a prescription.
It is particularly important to tell your doctor if you are taking:

• medicines containing corticosteroids
• antifungals, such as ketoconazole or itraconazole
• medicines that contain disulfiram or metronidazole (see “BUDIAIR contains glycerol and ethanol”)
• HIV protease inhibitors or other potent CYP3A4 inhibitors
• estrogens and contraceptive steroids

Some medicines can increase the effects of BUDIAIR and your doctor may want to monitor you closely if you are taking these medicines (including some medicines for the treatment of HIV: ritonavir, cobicistat).
If you are taking any of the medicines mentioned above, your doctor may prescribe you another medicine or adjust the dose of BUDIAIR or the other medicine.
If you undergo an ACTH stimulation test for the diagnosis of pituitary insufficiency, the test may show false results (low values).
Your doctor may have given you other medicines for your breathing problems. It is very important to continue to use these products regularly. DO NOT STOP USING THEM and do not change the dose when you start using BUDIAIR.
10

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
If you become pregnant while taking BUDIAIR, consult your doctor immediately.
Worldwide experience with inhaled budesonide has not been able to detect an increased risk of adverse effects for the fetus and newborn during pregnancy.
Budesonide can be taken during breastfeeding.

Driving and using machines
BUDIAIR does not impair your ability to drive or use machines.

BUDIAIR contains glycerol and ethanol.
This medicine contains 8.4 mg of alcohol (ethanol) per actuation which is equivalent to 0.12 mg/kg per administration in adults and 0.42 mg/kg in children. The amount in one actuation of this medicine is equivalent to less than 1 ml of wine or beer. The small amount of alcohol in this medicine will not have noticeable effects.
Ethanol can cause problems in patients particularly sensitive treated with medicines containing disulfiram or metronidazole.
This medicine contains glycerol: it can cause headache, stomach upset and diarrhea.
Attention for those who play sports: the product contains substances prohibited for doping. An intake different from therapeutic indications, dosage regimen and route of administration is prohibited.

3. How to take BUDIAIR

BUDIAIR is for inhalation use.
Always take this medicine exactly as your doctor has told you. If you have any doubts, ask your doctor
or pharmacist.
Your doctor will check you regularly to make sure you are taking the optimal dose of BUDIAIR.
The doctor will adjust your treatment to the lowest dose (maintenance dose) that can best control your
symptoms. Under no circumstancesshould you change the dose without first talking to your
doctor.
It is important that you take BUDIAIR for the entire period prescribed by your doctor.
This medicine will take a few days to become effective. It is very important that you use it regularly.

Adults and adolescents
The recommended dose is 200 micrograms (one actuation) 2-4 times a day. The maintenance dose is
generally 200 micrograms (one actuation) per day.
The maximum daily dose is 1600 micrograms.
11

Use in children
Children aged 6 to 12 years
The recommended dose is 200 micrograms (one actuation) per day. The maximum daily dosage is
400 micrograms.
If BUDIAIR is to be used by your child, make sure he/she is able to use it correctly.
Inhalation in children should be supervised by an adult. It is useful to close the child's nostrils during
inhalation.

Taking corticosteroids
If you have just started using BUDIAIR instead of taking corticosteroid tablets or if you are taking higher
doses of corticosteroids by inhalation for long periods of time, you may need extra steroids
in stressful situations. Stressful situations can include being admitted to hospital after an accident, having
serious injuries or during periods before surgery. In this case, the doctor caring for you will decide if
you need to increase your dose of corticosteroids and may prescribe you some steroid tablets or an
steroid injection.

How to take BUDIAIR
See “Instructions for use of the inhaler” at the end of this leaflet.
It is recommended to rinse your mouth thoroughly with water, then spit it out, after each use of the aerosol
dose in order to reduce the risk of a possible Candida infection.

If you take moreBUDIAIR than you should
you must not increase or decrease the dose without first consulting your doctor.
If you happen to accidentally take too many doses, contact your doctor as soon as possible.

If you forget to take BUDIAIR
If you accidentally forget to take a dose, take the next dose normally. Do not take
a double dose to make up for a missed one.

If you stop taking BUDIAIR
Do not stop taking the treatment even if you feel better without talking to your doctor first. If
you suddenly stop taking this medicine, your asthma condition may worsen.

If your asthma gets worse
If your symptoms worsen or are difficult to control (e.g. if you are using your quick-relief asthma medication
more frequently) or if your quick-relief asthma medication does not improve your
symptoms, see your doctor immediately. Asthma may be getting worse and your doctor may
need to change your dose of BUDIAIR or prescribe you alternative treatment.
If you are switching from steroid tablets to inhaled therapy, you may not feel well, even if your chest symptoms
are improving. Talk to your doctor, but DO NOT STOP the treatment before you
are told to.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
12

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If side effects do occur, they are likely to be mild and temporary. However, some
effects can be serious and require medical attention.
Possible side effects are listed below:

Common(may affect up to 1 in 10 people)
Change in voice (hoarseness), cough, sore throat, fungal infections of the mouth (oropharyngeal candidiasis),
difficulty swallowing.

Uncommon(may affect up to 1 in 100 people)
Anxiety, depression, tremor, cataract, blurred vision, muscle spasms

Rare(may affect up to 1 in 1,000 people)
Easy bruising, thinning of the skin, skin rash or hives, skin inflammations
(dermatitis), itching, abnormal skin redness (erythema), anaphylactic reactions, angioedema, levels
too high or too low of cortisol in the blood (hypercortisolism or hypocortisolism), narrowing of the
airways (bronchospasm).
Restlessness, nervousness, irritability, mental disorders (psychosis), and behavioral changes. These effects
occur more frequently in children.

Very rare (may affect up to 1 in 10,000 people)
Taste abnormalities and alterations (dysgeusia), nausea, burning sensation on the tongue (glossodynia), inflammation of the
mouth (stomatitis), dry mouth, back pain.

Not known (frequency cannot be estimated based on available data)
Sleep problems, aggressive reactions and increased psychomotor activity (mainly in children).
Increased pressure in the eyeball (glaucoma).

Rare serious allergic reactions
If they appear shortly after taking a dose, itching, allergic reaction with skin redness, swelling of the
face, very low blood pressure and irregular heartbeat (anaphylactic reaction), swelling of the face, eyes,
lips, tongue, throat or difficulty breathing (angioedema), immediate or delayed allergic reactions:

• stop taking BUDIAIR
• seek medical attention immediately

Shortness of breath immediately after taking a dose
Rarely, inhaled medicines can cause an increase in wheezing and shortness of breath (bronchospasm)
immediately after administration. If this happens:

• stop using BUDIAIR immediately
• use your quick-relief asthma inhaler immediately to treat the symptoms of shortness of breath and wheezing.
• contact your doctor immediately

13

The use of high doses of inhaled corticosteroids for long periods may cause systemic effects
Rarely delayed growth in children and adolescents and adrenal gland dysfunction
(adrenal suppression), very rarely reduced bone mineral density (thinning of the
bones).
With unknown frequency, sleep disorders may occur (more likely in children).

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the national
reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store BUDIAIR

• Keep this medicine out of the sight and reach of children
• Do not use this medicine after the expiry date which is stated on the label and the package. The expiry date refers to the last day of that month
• Store the inhaler below 25 C
• The container contains a pressurized liquid. Do not puncture, expose to heat, even if empty, do not freeze or expose to direct sunlight
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer need. These measures will help to protect the environment.

6. Package contents and other information

What BUDIAIR contains
The active substance is budesonide. Each actuation delivers 200 micrograms of budesonide.
The other ingredients are: norflurane (HFC 134a), anhydrous ethanol and glycerol.
This medicine contains fluorinated greenhouse gases.
Each inhaler contains 11,200 g of norflurane (HFC-134a) which corresponds to 0.016 tonnes of
CO2 equivalent (global warming potential GWP = 1430).

What BUDIAIR looks like and contents of the pack
BUDIAIR is a pressurised inhalation solution contained in an aluminium canister with a JET spacer
device made of plastic.
Each pack contains 1 inhaler which delivers 200 doses.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Chiesi Farmaceutici S.p.A., via Palermo 26/A, 43122 Parma, Italy

Manufacturer
Chiesi Farmaceutici S.p.A, Via San Leonardo 96, 43122 Parma, Italy
14

Alternative batch release:
All-Gen Pharmaceuticals & Generics BV, Rouboslaan 32 – 2252 TR Voorschoten – Netherlands
Chiesi Pharmaceuticals GmbH – Gonzagagasse 16/16 – 1010 Vienna – Austria

This medicinal product is authorised in the Member States of the European Economic Area with the following
names:
Italy BUDIAIR
Greece BUDIAIR
Netherlands Budesonide All-Gen
Poland BUDIAIR
Czech Republic BUDIAIR
Slovenia BUDIAIR
15

Instructions for use for your inhaler
BUDIAIR is easy to use. Read all these instructions before using it: they will tell you what you must do and what
you should pay attention to.

Opening the pack
Figure 1 When opening the pack, the Jet spacer device is closed with the mouthpiece cap.

Taking a dose from BUDIAIR
Figure 2 Remove the mouthpiece cap from the Jet spacer device and hold it as shown
in the illustration.
Figures 3 a-b Breathe out deeply (3a), then place the mouthpiece firmly between your lips (3b).
Figure 4 Press the canister with your index finger and inhale deeply, even for a few seconds (it
is possible to take more than one inhalation through the Jet)
Figures 5 a-b After inhalation, hold your breath for as long as possible (5a), then close the Jet with the
mouthpiece cap (5b).

Cleaning
Figure 6 The Jet must always be kept clean. To clean it, remove the pressurised canister and
rinse the Jet spacer device with lukewarm water. Allow to dry completely
in a warm place. Avoid excessive heat.
1 2 3a 3b
4 5a 5b 6
16